Study to Evaluate Potential Decrease in Hospitalization Events, Time Between Events, and Increasing Longevity in Patients With Symptomatic Heart Failure (0954-948)
A Multi-center, Double-Blind, Randomized, Parallel Group Study to Evaluate the Effects of Two Different Doses of Losartan on Morbidity and Mortality in Patients With Symptomatic Heart Failure Intolerant of ACE Inhibitor Treatment
2 other identifiers
interventional
3,834
0 countries
N/A
Brief Summary
This is a multicenter study to evaluate potential decrease in hospitalization events and time between events and increasing longevity in patients with symptomatic congestive heart failure and intolerant of first-line medication for heart failure. This study will evaluate if higher doses of the investigational drug given daily will be superior to the lower dose of the same investigational drug given daily.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 heart-failure
Started Dec 2001
Longer than P75 for phase_3 heart-failure
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 19, 2001
CompletedFirst Submitted
Initial submission to the registry
August 25, 2004
CompletedFirst Posted
Study publicly available on registry
August 27, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 13, 2009
CompletedResults Posted
Study results publicly available
August 2, 2010
CompletedMay 16, 2024
February 1, 2022
7.3 years
August 25, 2004
June 30, 2010
May 8, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants That Experienced One Component of the Composite Clinical Endpoint of All Cause Death or Hospitalization for Heart Failure
Entire follow-up (median = 4.7 years)
Secondary Outcomes (4)
Number of Participants That Experienced One Components of the Composite Clinical Endpoint of All Cause Death or Cardiovascular Hospitalization
Entire follow-up (median = 4.7 years)
Number of Participants That Died (Any Cause)
Entire follow-up (median = 4.7 years)
Number of Participants That Were Hospitalized for Heart Failure
Entire follow-up (median = 4.7 years)
Number of Participants That Experienced Cardiovascular Hospitalization
Entire follow-up (median = 4.7 years)
Study Arms (2)
Losartan 50 mg
EXPERIMENTAL50-mg losartan tablet administered daily with 1 tablet of 100-mg losartan placebo beginning Week 1 and continuing to end of study (up to 4 years)
Losartan 150 mg
EXPERIMENTALTitrated losartan administration up to daily 150-mg losartan: Week 1, daily 50-mg losartan tablet coadministered with 100-mg losartan placebo; Week 2, daily 50-mg losartan placebo coadministered with 100-mg losartan; Week 3 to end of study (up to 4 years), daily 50-mg losartan tablet coadministered with 100-mg losartan
Interventions
100-mg losartan oral tablet + 50-mg losartan oral tablet
Eligibility Criteria
You may qualify if:
- Symptomatic heart failure with known or recently diagnosed intolerance of treatment with first-line medication for heart failure
- May or may not be receiving an alternative and/or additional drug treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Organon and Colead
Related Publications (4)
Upshaw JN, Konstam MA, Klaveren Dv, Noubary F, Huggins GS, Kent DM. Multistate Model to Predict Heart Failure Hospitalizations and All-Cause Mortality in Outpatients With Heart Failure With Reduced Ejection Fraction: Model Derivation and External Validation. Circ Heart Fail. 2016 Aug;9(8):e003146. doi: 10.1161/CIRCHEARTFAILURE.116.003146.
PMID: 27514751DERIVEDRossignol P, Girerd N, Gregory D, Massaro J, Konstam MA, Zannad F. Increased visit-to-visit blood pressure variability is associated with worse cardiovascular outcomes in low ejection fraction heart failure patients: Insights from the HEAAL study. Int J Cardiol. 2015;187:183-9. doi: 10.1016/j.ijcard.2015.03.169. Epub 2015 Mar 17.
PMID: 25828348DERIVEDKiernan MS, Gregory D, Sarnak MJ, Rossignol P, Massaro J, Kociol R, Zannad F, Konstam MA. Early and late effects of high- versus low-dose angiotensin receptor blockade on renal function and outcomes in patients with chronic heart failure. JACC Heart Fail. 2015 Mar;3(3):214-23. doi: 10.1016/j.jchf.2014.11.004.
PMID: 25742759DERIVEDKonstam MA, Neaton JD, Dickstein K, Drexler H, Komajda M, Martinez FA, Riegger GA, Malbecq W, Smith RD, Guptha S, Poole-Wilson PA; HEAAL Investigators. Effects of high-dose versus low-dose losartan on clinical outcomes in patients with heart failure (HEAAL study): a randomised, double-blind trial. Lancet. 2009 Nov 28;374(9704):1840-8. doi: 10.1016/S0140-6736(09)61913-9. Epub 2009 Nov 16.
PMID: 19922995DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2004
First Posted
August 27, 2004
Study Start
December 19, 2001
Primary Completion
March 31, 2009
Study Completion
May 13, 2009
Last Updated
May 16, 2024
Results First Posted
August 2, 2010
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share